(65 days)
Not Found
No
The description focuses on the physical design and function of a diagnostic catheter for recording electrical signals, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as a "Diagnostic Catheter" used for "recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies" and to "map the atrial regions of the heart", indicating a diagnostic purpose rather than therapeutic.
Yes
The first sentence of the "Intended Use / Indications for Use" section explicitly states "The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies." The term "diagnostic" is directly used.
No
The device description clearly details a physical catheter with electrodes, a connecting cable, and a steerable handle, indicating it is a hardware device, not software-only.
Based on the provided information, the Inquiry™ AFocusII™ Diagnostic Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies" and to "map the atrial regions of the heart." This involves direct interaction with the patient's body (intracardiac) to gather electrical signals.
- Device Description: The description details a catheter that is inserted into the body and has electrodes to record signals from within the heart.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device operates inside the body.
Therefore, the Inquiry™ AFocusII™ Diagnostic Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.
The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial regions of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
electrophysiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
K101623
p 1/2
Section 14
Summary Of Safety And Effectiveness
AUG 1 3 2010
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.
- Submitter's name, address, telephone number, contact person, and date summary 1. prepared:
| a. | Submitter: | Irvine Biomedical, Inc.
a St. Jude Medical Company
2375 Morse Avenue
Irvine, CA 92614
Tel. (949) 769-5000 |
| ---- | ------------ | ----------------------------------------------------------------------------------------------------------------------- |
|---|
- b. Contact Person: Quynh Phuong Le Regulatory Affairs Specialist II Tel. (949) 769-5058
- Date Summary Prepared: June 8, 2010 C.
2. Name of device, including trade name and classification name:
- Trade/Proprietary Name: InquiryTM AFocusIITM Diagnostic Catheter a.
- Catheter, Electrode Recording b. Classification names:
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Irvine Biomedical, Inc
a St. Jude Medical Company |
|---------------|--------------------------------------------------------|
| Device: | Inquiry™ AFocusII™ Steerable Electrophysiology Cathete |
| 510(k): | K042775 |
| Date Cleared: | November 4, 2004 |
Company: St. Jude Medical Reflexion HDTM High-Density Mapping Catheter Device: 510(k): K080179 Date Cleared: January 7, 2009
1
K101623
p 2/2
A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices.
The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
Statement of intended use: 5.
The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic catheters are to be used to map the atrial regions of the heart.
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The Inquiry™ AFocusII™ Diagnostic Catheter and its predicate devices are intended for electrogram recording and stimulation during electrophysiological studies. The encertifications do not affect the intended use or scientific technology of the device, as embodied in the catheter.
Brief summary of nonclinical tests and results: 7.
The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
100 13 WW
St. Jude Medical c/o Ms. Quynh Phuong Le Regulatory Affairs Specialist II Atrial Fibrillation Division 2375 Morse Avenue Irvine, CA 92614-6233
Re: K0101623
Trade/Device Name: Inquiry AFocusII Diagnostic Catheter Regulatory Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: DRF Dated: June 08, 2010 Received: June 09, 2010
Dear Ms. Le:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Quynh Phuong Le
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.W.S.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 13
Indications for Use
510(k) Number (if known): K101623
AUG 13 2010
Device Name: InquiryTM AFocusII™ Diagnostic Catheter
Indications for Use:
The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number
Page . of
13-1